Summary

Urogenital Chlamydia trachomatis infection is the most common bacterial sexually transmitted
infection in Norway. Urogential C.trachomatis infection can easily be treated with
antibiotics. However, left untreated it is a major cause of pelvic inflammatory disease
(PID) that can lead to complications such as infertility, ectopic pregnancy and chronic
pelvic pain in women. Most infections are asymptomatic and many do not seek the doctor for
testing. Therefore cases remain undetected and untreated.We want to determine the efficacy
and feasibility of screening for urogenital C. trachomatis infection with home sampling
(intervention) compared to the current strategy of conventional sampling at the doctor's
office (control) in identifying men and women aged 18-25 years with urogenital C.trachomatis
infection (Part A). We also want to identify factors influencing the acceptability of home
sampling for C.trachomatis infections (Part B)and determine factors associated with
C.trachomatis infections (Part C).

Description

Study design The different objectives will be addressed through a complex design with
several sub-studies.

Part A is a randomised control trial where we compare the intervention group who will be
offered home-sampling and recieve a package by mail (containing information on urogenital
C.trachomatis infections, sampling eqiupment for urine tests and a questionnaire) with a
control group who will continue with todays system of conventional sampling at the doctores
office (no intervention). The study population are all men and women between 18-25 years of
age in Rogaland County in Norway. The population register will be used to randomly assigne
to either the intervention group or the control group.The intervention group will be asked
to take a urine sample and send this by mail to the laboratory for analysis within three
months after the invitation, and to fill out and return a questionnaire. For the ones in the
control group all samples(urethral or cervical swabs or urine samples)taken within the same
three months will be sendt to the same laboratory. In this part of the study we will measure
the yield ratio for the tested, diagnosed and treated in the two groupsafter the study
period of three months. All samples either obtained at home or at the physician's office,
will be analyzed by BDProbeTec ET Chlamydia Amplified DNA assay. This is a well documented
Nucleid Acid amplification method. Samples will be analysed according to manufactures
instructions. Data on number of tested and diagnosed in the two groups will be collected
from Stvanger University Hospital. Data on number of treated will be collected from the
Norwegain Prescription Database by merging the study dataset with their datafiles. This way
we will recive information on who has received treatment for C.rachomatis within one month
after after a positive C.trachomatis test.

In Part B a case-cohort from the intervention group (Part A) consisting of a random
selection of respondents and non-respondents will be used to determine the feasibility of
home sampling as a screening strategy by measuring the risk (OR) related to different
factors that determined response. Data are collected through selfadminitered questionnaires.

Part C is a cross sectional study consisting of all respondents in the intervention group.
In this part we will measure Prevalence Ratio(PR) of urogential C.trachomatis infections
associated with different factors by comparing C.trachomatis positive and C.trachomatis
negative in the intervention group.

Part D is an economic study which will be addressed in a separate protocol.

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Chlamydia trachomatis is the most prevalent bacterial sexually transmitted infection (STI) in the world. Approximately 80% of infected women are asymptomatic, although this infection can lead to serio...

Sexually transmitted infections (STI) can have major consequences for the reproductive health of women. Mycoplasma genitalium is a STI that is not as well studied but causes pelvic inflammatory diseas...

Medical and Biotech [MESH] Definitions

Chlamydia Muridarum

Species of CHLAMYDIA causing pneumonitis in mice and hamsters. These isolates formerly belonged to CHLAMYDIA TRACHOMATIS.

Chlamydia Trachomatis

Type species of CHLAMYDIA causing a variety of ocular and urogenital diseases.

Chlamydia

A genus of the family CHLAMYDIACEAE whose species cause a variety of diseases in vertebrates including humans, mice, and swine. Chlamydia species are gram-negative and produce glycogen. The type species is CHLAMYDIA TRACHOMATIS.

Trachoma

A chronic infection of the CONJUNCTIVA and CORNEA caused by CHLAMYDIA TRACHOMATIS.

Chlamydophila

A genus of the family CHLAMYDIACEAE comprising gram-negative non CHLAMYDIA TRACHOMATIS-like species infecting vertebrates. Chlamydophila do not produce detectable quantities of glycogen. The type species is CHLAMYDOPHILA PSITTACI.

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